Cosmetic or pharmaceutical composition for topical application

ABSTRACT

A cosmetic or pharmaceutical composition, to be applied topically is described, which has a hydrophilic outer phase, at least one cosmetic and/or pharmaceutical active ingredient and at least one carrier substance for the active ingredient. The carrier substance here forms such structures, which comprises at least two lamellar double membrane layers arranged one over another in the manner of a sandwich, wherein between adjacent double membrane layers, aligned parallel to each other, a layer of an inner phase is respectively arranged. The active ingredient is distributed in the double membrane layer and in the layer of the inner phase such that the layer of the inner phase contains the active ingredient in a concentration range between 2% by weight and 98% by weight and the double membrane layer contains the active ingredient in a concentration between 98% by weight and 2% by weight, respectively in relation to the total concentration of active ingredient, and the outer phase has no or almost no active ingredient.

The present invention relates to a cosmetic or pharmaceuticalcomposition, to be applied topically, with the features of theintroductory clause of patent Claim 1.

Cosmetic or pharmaceutical compositions which are to be appliedtopically are known with different ingredients and are also widely-used.Here, only by way of example, the typical oil-in-water emulsions orwater-in-oil emulsions, the gels, ointments or lotions are to bementioned, wherein jointly for the above-mentioned known compositions,their object is to be formulated in that they possess a certain cosmeticor pharmaceutical effectiveness, which after local application mustoccur after a certain time.

A cosmetic or pharmaceutical composition which is to be appliedtopically, which has a hydrophilic outer phase, at least one cosmeticand/or pharmaceutical active ingredient and at least one carriersubstance for the active ingredient and in which at least one carriersubstance is present which forms such structures in which at least twolamellar double membrane layers, arranged one over another in the mannerof a sandwich, are present, is first mentioned in DE 102 13 304 A.However, this German patent application, which originates from the sameapplicant as the present application, emphasizes as the main focus thatthe hydrophilic phase is water and that furthermore the knowncomposition must contain as essential ingredients methylglycine,dimethylglycine and/or methylmethionine. DE 102 13 304 A leaves open howthe pharmaceutical active ingredient is distributed in the knowncomposition. Such a statement is also not found in DE 101 08 097 A,which likewise originates from the applicant of the present application,because this application, directed to a cosmetic composition, likewiserefers as the main focus to the fact that in the known composition inparticular the ingredients methylglycine, dimethylglycine and/ormethylmethionine must be contained.

In addition to this prior art, reference is made to DE 10 2006 015 544for which application was previously made, but which is not yetpublished, which likewise originates from the applicant of the presentapplication, wherein in this application compositions which are to beapplied topically are previously described for use with babies orinfants, such that the known compositions described there have aparticular active ingredient, which is an anti-inflammatory activeingredient which is poorly soluble in a hydrophilic liquid. In thepreviously applied for and subsequently published DE 10 2006 015 544,this anti-inflammatory active ingredient which is poorly soluble in thehydrophilic liquid is dispersed homogeneously in the material whichforms the lamellar double membrane layer, so that accordingly thehydrophilic liquid surrounding the double membrane layer is free ofanti-inflammatory active ingredients.

The present invention is based on the problem of providing a cosmetic orpharmaceutical composition, to be applied topically, which has aparticularly marked cosmetic or respectively pharmaceuticaleffectiveness, taking into account a high storage stability.

This problem is solved according to the invention by a cosmetic orpharmaceutical composition, to be applied topically, with thecharacterizing features of patent Claim 1.

The inventive cosmetic or pharmaceutical composition, to be appliedtopically, which is also designated below in abbreviated form only asinventive composition, has a hydrophilic outer phase and furthermorecontains at least one cosmetic and/or pharmaceutical active ingredient.Furthermore, the inventive composition comprises at least one carriersubstance for the active ingredient, wherein the carrier substance formssuch structures, which has at least two lamellar double membrane layersarranged one over another in the manner of a sandwich. Between adjacentdouble membrane layers, aligned parallel to each other, in the inventivecomposition a layer of an inner phase is respectively arranged. UnlikeDE 10 2006 015 544, in the inventive composition the active ingredientis distributed in the double membrane layer and in the layer of theinner phase such that the layer of the inner phase contains the activeingredient in a concentration range between 2% by weight and 98% byweight and the double membrane layer contains the active ingredient in aconcentration between 98% by weight and 2% by weight, respectively inrelation to the total concentration of the active ingredient present inthe inventive composition, whereas the outer phase, i.e. the phase whichsurrounds the particular structure from the exterior, contains no oralmost no active ingredient. The previously expressed statement,according to which the inventive composition contains no or almost noactive ingredient in the outer phase, means in particular that in thisouter phase, which viewed as a whole surrounds and embeds the particularlamellar structure and which differs from the layer of the inner phase,which is arranged exclusively between adjacent double membrane layers,in particular a maximum of 5% of the active ingredient is to be found,in relation to the total concentration of the active ingredient in theinventive composition.

The inventive composition has a range of advantages. Firstly, it istherefore to be recorded that the inventive composition, due to itsparticular structure, as has been previously described, is adsorbed inthe manner of a layer on the surface of the skin and/or is embedded inthe manner of a layer into the intercellular lipid layer, so thatalready solely therefrom ideal conditions exist for an optimumpenetration and hence also, depending on the respective activeingredient, a rapid permeation of the active ingredient. In particular,the inventive composition is suited to embed itself in voids of theintercellular lipids owing to its structural similarity with theintercellular lipids, so that here between the intercellular lipids andthe structurally similar inventive composition an intimate contact takesplace, which in turn accelerates the previously described penetrationand permeation of the active ingredient and hence establishes a highcosmetic and/or pharmaceutical effectiveness. Due to the fact thatwithin the inventive composition the active ingredient is distributedboth in the lipophilic double membrane layer and also in the layer ofthe inner phase, arranged between adjacent double membrane layers,during the application of the inventive composition a constant anddynamic new reinstatement of a balance takes place within thisparticular structure as soon as the active ingredient from theparticular structure of the inventive composition penetrates into thesurface of the skin. Accordingly, a constantly consistent flow of activeingredient takes place from the composition into the regions of the skinwhich are treated therewith, so that owing to the consistent penetrationthe particularly high cosmetic and/or pharmaceutical effectiveness ofthe inventive composition becomes explicable. This previously mentionedconsistent penetration of the active ingredient, for such pharmaceuticalactive ingredients which act not only locally but also systemically, isregarded as the reason for the fact that as a result of the consistentpenetration also a consistent permeation results, so that a systemicactive ingredient, embedded in such a way in the previously describedstructure of the inventive composition, is available systemically in aconsistent concentration over a long period of time, thus for examplebetween two hours and 18 hours. Owing to the previously alreadymentioned similarity of the structure of the inventive composition withthe structure of the surface fats and in particular with the structureof the intercellular lipids, the inventive composition is able tobalance structural defects in the intercellular lipids and to act therelike a filler substance, so that such voids are repaired correspondinglyby means of the inventive composition and accordingly the skin istransferred into a healthy structure again, so that it can carry out thefull protective function. Hereby, the skin is prevented from drying outto an elevated extent at these voids, bacteria, viruses or allergens areprevented from embedding themselves at the voids and, if applicable, areprevented from penetrating from there into the deeper layers of the skinand hence serving as the cause for inflammatory, superficially occurringskin irritations or skin inflammations, whereby, viewed as a whole, thehigh cosmetic effectiveness of the inventive composition becomesexplicable. In addition to this, the inventive composition can not onlybe used, as previously described, for the treatment of damaged skin, butowing to its particular structure, the inventive composition can also beused prior to the actual skin damage, i.e. therefore as a protectivefunction, so that accordingly the skin is not even damaged at all. Sucha skin protection, which in particular protects the healthy skin fromaggressive external interventions, such as for example extreme lightirradiation, aggressive media, salt water, environmental noxa or soaps,which owing to their emulsifier content and their frequent applicationdamage the surface lipids and in particular the intercellular lipids,are effectively attenuated by the inventive composition, because theinventive composition, owing to its structure and the previouslydescribed distribution of the active ingredients is pre-eminentlycompatible with the surface lipid layer of the skin. The high cosmeticeffectiveness of the inventive composition in the field of skinprotection is ascribed to this, especially since the inventivecomposition is able to embed both lipophilic active ingredients and alsolipophobic active ingredients simultaneously and in the proportionsquantified in the introduction in the inventive composition within thelipophilic double layer and the inner phase. Through the fact that inthe inventive composition the outer phase has no or almost no activeingredient, the inventive composition has a high storage stability,because here the active ingredient is distributed between the doublemembrane layer and the layer of the inner phase and is quasiencapsulated there, so that this active ingredient, which is thusembedded, is effectively protected in particular with respect to ageinginfluences brought about by increased temperature and/or oxidativeattacks. The previously described advantages of the inventivecomposition explain not only the high therapeutic effect but alsolikewise the high prophylactic effect of the inventive composition inthe cosmetic and pharmaceutical fields.

In order to demonstrate the previously described particular structure ofthe inventive composition experimentally, the possibility exists, hereas a measurement and demonstration method, to firstly prepare scanningelectron microscope exposures which permit initial informationconcerning the layer structure. For this, in particular the compositionswhich are to be examined are subjected to a freeze fracture preparation.After this, generally a freeze fracture etching takes place with asubsequent coating by vaporization with a platinum/carbon substrate.Such a preparation is examined and displayed electron microscopically.Further more detailed information concerning the particular lamellarstructures which have been previously described and are also displayedbelow in the drawings, which are an essential feature of the inventivecomposition, are permitted by isothermal titration calorimetry (ITC),infrared spectroscopy and/or differential scanning calorimetry (DSC), asare described in detail for example in “Bioelectrochemistry ofMembranes, ed. by D. Walz, J. Teissié and G. Milazzo, 2004 BirkhäuserVerlag Basel/Switzerland” in particular “Chapter 3, Lipids” Author:Alfred Blume, pages 61 to 152 (with further literature references) and“Handbook of Thermal Analysis and Calorimetry, Vol 4: FromMacromolecules to Man., R.B. Kemp, 1999 Elsevier Press B.V., Amsterdam,pp 109-173” (with further literature references).

It has previously been described in connection with the inventivecomposition that it is applied topically. In the present case, this isunderstood to mean that the inventive composition is to be applied bothon the external skin and also on mucous membranes of any kind.

A first further development of the inventive composition makes provisionthat here the inner phase contains the active ingredient in aconcentration range between 15% by weight and 85% by weight, preferablyin a concentration range between 25% by weight and 75% by weight, andthe double membrane layer contains the active ingredient in aconcentration range between 85% by weight and 15% by weight, preferablyin a concentration range between 75% by weight and 25% by weight,respectively in relation to the total concentration of activeingredient. This further development of the inventive composition,compared with the inventive composition described in the introduction,makes provision that here the active ingredient is distributedsystematically to both phases, i.e. to the inner phase and the doublemembrane layer, in appreciable concentrations, so that accordingly bothphases contribute to the penetration of the active ingredient, describedin the introduction, and hence also the permeation of the activeingredient, in so far as this is to act systemically, being influencedand optimized.

Basically, in the inventive composition the possibility exists that theconcentration of the active ingredient in the inner phase and theconcentration of the active ingredient in the double membrane layer areidentical. However, it is particularly advantageous if here theconcentrations of the active ingredient in the inner phase and in thedouble membrane layer differ from each other, because hereby thepossibility is created to influence the penetration speed of the activeingredient.

As already previously stated in the inventive composition, the outerphase which surrounds the particular structure consisting of at leasttwo double membrane layers with a layer of the inner phase arrangedthere between, has the active ingredient in a concentration of up to amaximum of 5% by weight in relation to the total concentration of activeingredient. However, it is particularly suitable if the outer phasecontains an active ingredient concentration of up to a maximum of 3% byweight and in particular an active ingredient concentration between 2%by weight and 1% by weight and preferably an active ingredientconcentration between 1% by weight and 0% by weight, respectively inrelation to the total concentration of active ingredient, because with adecreasing active ingredient concentration in the outer phase, thereproducibility of the penetration of the active ingredient and hencealso its permeation, in so far as the active ingredient actssystemically, can be influenced in a systematic manner. Furthermore, inthis further development of the inventive composition, it is ensuredthat the decomposition of active ingredient, by which in particular theactive ingredient contained in the outer phase is affected, isconsiderably reduced, which in turn has an influence on the storagestability of the inventive composition.

Another development of the inventive composition makes provision thathere the composition contains a hydrophobic active ingredient, whereinthe hydrophobic active ingredient is arranged predominantly, preferablyof at least 70% by weight and in particular of at least 80% by weight,in relation to the total concentration of active ingredient, inside thedouble membrane layer. Preferably, such developments of the inventivecomposition are possible in which the hydrophobic active ingredient isembedded inside the double membrane layer in a concentration between 80%by weight and 90% by weight in relation to the total concentration ofactive ingredient, wherein through such an embedding into the doublemembrane layer, which is a component of the particular structure of theinventive composition, the active ingredient is particularly wellprotected against the influences of ageing and/or of the environment.With this particular development, in which the hydrophobic activeingredient is embedded in a concentration between 80% by weight and 90%by weight, in relation to the total concentration of active ingredient,which is provided in the inventive composition, the inner phasetherefore has a maximum concentration of active ingredient between 20%by weight and 10% by weight in relation to the total concentration ofactive ingredient within the inventive composition, in so far as theouter phase is free of active ingredient. During the application of suchan embodiment of the inventive composition, the transport of the activeingredient out of the double membrane layer into the surface lipidsand/or intercellular lipids then takes place, so that at the same timethe proportion of active ingredient which is transported off from theinventive composition from the double membrane layer is subsequentlydelivered through the inner phase into the double membrane layer. Over acertain period of time, this leads to the active ingredientconcentration remaining constant inside the double membrane layer, withthe result that the active ingredient transport rate from the doublemembrane layer into the previously mentioned skin lipids remainsconstant.

Another, particularly suitable embodiment of the inventive compositionmakes provision that here a hydrophilic active ingredient is contained,wherein the hydrophilic active ingredient is arranged predominantly,preferably of at least 70% and in particular in a concentration rangebetween 80% by weight and 90% by weight, in relation to the totalconcentration of active ingredient, inside the inner phase. Thisdevelopment also allows, as previously described for the hydrophobicactive ingredient, for a consistent transport rate of the activeingredient to the skin to be guaranteed within a particular period oftime.

The previously described active ingredient distribution between thedouble membrane layer and the layer of the inner phase is initiallydirected, in the inventive composition, to which active ingredient is tobe embedded inside the structure which is characterized by the inventivecomposition, wherein for this in addition to intermolecular interactionsof the active ingredient with the material of the double membrane layerand the material of the inner phase, also the nature of the respectiveactive ingredient is decisive. If, for example, an active ingredient isconcerned which possesses lipophilic and hydrophilic characteristics toan equal extent, then such an active ingredient will preferably embeditself at 50% by weight inside the double membrane layer and at 50% byweight inside the inner phase, in so far as this inner phase ishydrophilic, wherein these concentration data refer to the totalconcentration of the active ingredient within the inventive composition.By variation of the lipophilia of the material which forms the doublemembrane layer and by variation of the hydrophilia of the material whichforms the inner phase, this previously described distribution balancecan be shifted so that accordingly an increase to the active ingredientconcentration takes place in the material which forms the doublemembrane layer, and a reduction of the concentration of the activeingredient takes place in the material which forms the layer of theinner phase and, naturally, vice versa.

A further possibility for influencing the active ingredient distributionbetween the double membrane layer and the layer of the inner phase inthe inventive composition makes provision that here the activeingredient is anchored or respectively embedded within the compositionby means of a lipophilic compound (anchor group) to or in the doublemembrane layer. In particular by variation of the stoichiometric ratiosof lipophilic compound to the active ingredient and by selection andcoordination of the lipophilic compound to the respective activeingredient or respectively the material from which the double membranelayer is formed, the lipophilic compound can be embedded and hence fixedin the double membrane layer and the active ingredient which is anchoredherewith can be optionally arranged at the boundary layer between thedouble membrane layer and the layer of the inner phase, wherein it isparticularly preferred if the lipophilic compound is embedded in thedouble membrane layer and the active ingredient which is anchoredherewith is arranged within the inner phase.

In the previously described embodiment of the inventive composition, inwhich the active ingredient is anchored by means of a lipophiliccompound, preferably such a lipophilic compound is provided in which theactive ingredient, which is preferably a hydrophilic active ingredientand/or an amphiphilic active ingredient, is fixed to the lipophiliccompound by intermolecular interactions, in particular by hydrogenbonding or by Van der Waals forces. An active ingredient which is fixedin such a way will then only be released in a delayed manner onapplication of this embodiment of the inventive composition, so thatthis development of the inventive composition has a good sustainedrelease effect.

If through such a compound (anchor group) the hydrophilic and/oramphiphilic active ingredient is to be fixed to the double membranelayer in the manner described above, such compounds present themselvesfor this which on the one hand still have reactive groups by which therespective active ingredient is coupled to the compound (anchor group)and which on the other hand still have a certain lipophilia, in order tobring about the previously described embedding and/or adsorption of thiscompound in and/or on the double membrane layer. Suitable compounds aretherefore in particular organic amphiphilic substances or organicsubstances with corresponding reactive centres, thus preferably alllonger chain hydrocarbon compounds, whether they are linear or cyclic(mono- and polycyclic, homo- and heterocyclic), which are additionallyprovided with halogen-, hydroxy-, acid-, ester-, acid amide-, amino-,imino-, acid imide- and/or other polar groups. To be mentioned here asparticular groups are preferably saturated and/or unsaturatedC₃-C₂₄-mono-bis tripeptides, alkanol amides, in particular ethanolamines of the C₁₄-C₂₄ fatty acids, C₁₀-C₂₄ fatty acids (saturated andunsaturated), C₁₀-C₂₄-fatty acid salts, C₁₀-C₂₄-fatty alcohols and/orC₁₀-C₂₄-fatty acid esters.

Basically, with the inventive composition the possibility exists thatthe material of the inner phase and the material of the outer phase aredifferent wherein, however, it is preferred, in particular from thepoint of view of a longer storage stability of the inventivecomposition, that the inner phase and the outer phase are identical withregard to material. In particular, as material for the outer phase andpreferably therefore also as material for the inner phase respectively aliquid is selected, wherein the term liquid covers all liquid systems,the viscosity of which varies in particular between low viscous to highviscous and therefore comprises not only the viscosity of actual liquidsbut also the viscosity of gel-like preparations, in particular oleogels,and also foams.

In further development of the previously described embodiment of theinventive composition, in which the inner phase and the outer phase arerespectively a liquid, a modification of this embodiment makes provisionthat this liquid is respectively water. Here, this term water not onlycomprises distilled water, de-ionized water or osmotically purifiedwater, but also covers all aqueous systems, thus for example also buffersystems or salt solutions or such aqueous systems which in addition towater also contain physiologically harmless organic solvents which aremiscible with water.

As already previously mentioned repeatedly, the inventive compositionhas a locally acting active ingredient and/or a systemically actingactive ingredient, wherein with the selection of a locally acting activeingredient the statements previously expressed in the inventivecomposition concerning the penetration ability and with a systemicallyacting active ingredient the statements previously expressed with regardto a penetration and permeation of the active ingredient are to be takeninto consideration.

If the inventive composition has a pharmaceutical active ingredient,then this is preferably such a pharmaceutical active ingredient which isselected from the group which comprises analgesics, antirheumatics,antiallergics, antibiotics, antimycotics, antiphlogistics,balneotherapeutics, corticoid active ingredients, antiseptics,circulation-enhancing active ingredients, sedatives, anaesthetics,spasmolytics, wound treatment agents, antipruritics, such as inparticular polidocanol, benzocaine and/or lidocaine, antipsoriatics,such as in particular sphingosine-1-phosphate, dithranol and/orbecocalcidiol, anti-acne agents, such as in particular benzoylperoxide,doxicycline and/or vitamin A acid, anti-rosacea agents, such as inparticular metronidazole and/or vitamin K, antiherpetics, such as inparticular acyclovir, haemorrhoid agents, such as in particularbufexamac and/or lidocaine, venous therapeutic agents, such as inparticular heparinoids and/or horse chestnuts extract, immunomodulators,such as in particular tacrolimus and/or pimecrolimus, agents for thetreatment of skin cancer, such as in particular 5-fluorouracil and/orcyclooxygenase-2 inhibitors, respectively alone or in a mixture. Here,the respective pharmaceutical active ingredient is selected according towhich therapeutic problem the inventive composition is to solve with itstopical application, wherein the previously listed preferred activeingredients, in so far as they are compatible with each other, can alsobe applied as a mixture. The particular advantage of such a developmentof the inventive composition which contains a pharmaceutical activeingredient lies in that with a topical application of the inventivecomposition, skin irritations and skin excitations are avoided even whenthe active ingredient which is respectively present in the compositionis known to bring about corresponding skin irritations or skinexcitations.

Suitable analgesics which in particular act systemically are selected inparticular from the group of non-opioid analgesics and preferablycomprise the salicylic acid derivatives known per se, such as inparticular acetylsalicylic acid, amides of salicylic acid, salsalates,benorilates and difunisals, aniline derivatives, such as in particularparacetamol, phenacetin, anthranilic acid derivatives, such as inparticular mefenamic acid, flufenamic acid, nilfumic acid, pyrazolderivatives, azapropazones and heteroaryl- and aryl-acetic acids andarylpropionic acids.

Particularly to be mentioned as pharmaceutical active ingredients withregard to the antimycotics are the azol derivatives which are to beapplied topically, such as in particular fenticonazole, clotrimazole,econazole, isoconazole, ketoconazole, miconazole, oxiconazole,tioconazole, flutrimazole, the polyenes, such as in particularnyastatin, the cicloprioxolamines, such as in particular ciclopirox, theallylamines, such as in particular naftifine, terbinafine, and/or themorpholines, such as in particular amorolfine.

Particularly to be mentioned with regard to the corticoid activeingredients are cortisone, hydrocortisone, glucocorticoids and theirderivatives such as triamcinolonacetonide and other cortisonederivatives, which have a local effectiveness in particular with thetopical application.

Furthermore, depending on the field of application of the inventivecomposition, as pharmaceutical active ingredient an anti-inflammatoryactive ingredient, thus in particular bufexamac, chamomile extract,witch hazel extract, tannins, bisabolol, ammonium bituminosulphonate orallantoin, an immunosuppressive, such as in particular methotrexate,ciclosporin, reinoids, preferably isotretinoin, acitretinoin ortazarotene, or anti-infectives, such as in particular clindamycin,tetracyclins, or an antiseptic, such as in particular chlorhexidine,benzalconium chloride, 8-hydroxychinolins, ethacridine, hexatidine,acriflavinium chloride, benzoxonium chloride, bibrocathol, dequaliniumsalts, azelaic acid, resorcin, triclosan, farnesol, dicglycerolmonocaprinate, colloidal silver, silver salts, such as in particularsilver citrate, silver nitrate and/or silver chloride, or gentamycin, orvirustatics can be contained, wherein of course the inventivecomposition can also have several of the previously listed activeingredients.

In addition to the previously listed pharmaceutical active ingredientsor instead of the previously listed pharmaceutical active ingredients, aparticularly suitable embodiment of the inventive composition makesprovision that here the inventive composition contains at least onecosmetic active ingredient, which is selected from the group whichcomprises oils, fats, waxes, antioxidants, peptides, proteins, aminoacids, derivatives of amino acids, light-protective filters, tanningagents, vitamins, provitamins, fruit acids, humectants, parts of plantsand plant extracts, urea, glucans, glucan derivatives, organic metalcompounds and inorganic metal compounds.

Light-protective filters which are also occasionally designated as sunprotection filters in particular in cosmetic compositions, arepreferably selected from the group which comprises PABA and derivatives(=PEG-25, PABA), octyl dimethyl PABA, homosalates, oxybenzone BEMT,p-methoxycinnamate, ethylhexyl triazones, octocrylene, benzophenone-3,benzophenone-4, benzophenone-9, diethylamino hydroxybenzoyl hexylbenzoate, drometrizole trisiloxane, 4-methylbenzylidene camphor,3-benzylidene camphor, octyl salicylate, methylene bis-benzotriazolyltetramethylbutylphenol and bis-ethylhexyloxyphenol methoxyphenyltriazine, ethylhexyl methoxycinnamate, diethylhexyl butamido triazone,phenylbenzimidazole sulfonic acid, butyl methoxydibenzoylmethane,diethylamino hydroxybenzoyl hexyl benzoate, disodium phenyldibenzimidazole tetrasulfonate and terephthalylidene dicamphor sulfonicacid.

As antioxidants, in particular as a single substance or as a mixture inthe inventive composition are vitamins, in particular vitamin A and/orvitamin C, tocopherols, carcinin, liponic acid, liposol maleates,carotenoids, lycopenes, colourless carotenoids, in particular theIBR-TCLC isolated from tomato or the IBR-CLC isolated from algae,polyphenols, such as for example epicatechins, epigallocatechins,epigallocatechingallate and/or epicatechnin-3-gallate, caffeic acid,caffeic acid ester, rosmarinic acid, flavonoids which are preferablyisolated from tea, wine, coffee, cacao, rooibos, cocoa or grapeseedextract, thus in particular flavanols, flavanons, anthocyanidins,proanthocyanidins, resveratrol, silymarin, aspalathin, ellaginic acid,curcumin derivatives, dyhydroquercetin, N.D.G.A., rutin,tetrahydrocurcuminoid, tetrahydrodiferuloylmethane,tetrahydrodemethoxydiferuloylmethane,tetrahydrobisdemethoxydiferuloylmethane, glutathione, coenzyme q 10,L-carnosin, N-acetylcycsteine, phytic acid, furalglucytol, chelatingagents, thus in particular thioctic acid and/or EDTA, BHA, BHT, SOD,4-thiazolidinone kinetin. Furthermore, the inventive composition canalso have plant ingredients, which are produced in particular byextraction of plants, of parts of plants, of fruits, of peel and/or ofseeds of rosemary, hops, ginger, Picea abies extract and lignan leadsubstances isolated therefrom, such as in particularhydroxymatairesinol, matairesinol and secoisolaricirinol, Picea abiesextract, Pinus pinaster, pycnogenol, Uniprotect PT-3, Unirepair T-43(manufacturer: Induchem), bakuchiol, Coffea arabica, Quercus infectoria,Camelia sinensis, Olea europea, Rosmarinus officinalis, Artemisiaumbellifloris, Buddleia davidii, Leontopodium alpinum or by extractionof algae.

The preferred peptides are preferably selected from the group containingpentapeptides, hexapeptides, in particular hexapeptide-2 and/orhexapeptide-9, heptapeptides, copper peptides, growth factors of the TGFbeta family, MPC milk peptides, MTP milk tripeptides,palmitoyloligopeptides/matrikines, in particular Pal-KTTKS(manufacturer: Sederma) and/or Pal-VGVAPG (manufacturer: Sederma),acetylhexapeptide 3, palmitoylpentapeptides, palmitoyltripeptide-5,Serilesine (=laminin, manufacturer: Lipotec), Lipeptide (=Oligopeptide,manufacturer: Lipotec), tripeptide 10-citrulline, Aldenine(manufacturer: Lipotec), Myoxinol (manufacturer: Cognis), tripeptide-1,tripeptide-3, hexapeptide-9, hexapeptide-2, oligopeptide-6, dipeptide-4,decapeptide-2, Phytoquintescine (manufacturer: Vincience), glutathione,cytokin, soya oligopeptide, polygammaglutamic acid.

Preferred proteins are selected from the group which comprises collagen,collagen derivatives, Antarcticin (=glycoprotein, manufacturer:Lipotec), keratin, hydrolyzed wheat protein, soya protein, preferablyhydrolyzed and/or extracted soya protein, elastin and rice bran protein.

Particularly suitable amino acids or their derivatives are lysine,alanine, serine, glycine, arginine, glutamic acid, histidine, valine,cysteine and/or aminoguadine, wherein this amino acid or respectivelythe corresponding derivatives are contained in the inventive compositionin particular also as humectants. Further humectants preferably comprisecaprylyl glycol, urocanic acid, creatine, glucosamine, hyaluronic acid,hyaluronic acid ectoin, trehalose, lactobionic acid, taurine,xylitylglucoside anhydroxylitol xylitol (manufacturer: Seppic),aquaporin 3-synthesis stimulators, such as in particular opuntiaextract, lactic acid, pyrrolidone carboxylic acid, alphahydroxy acids orbetahydroxy acids, such as in particular hydroxycarboxylic acids,dicarboxylic acids, in particular gluconic acid, citric acid, malicacid, tartaric acid, their derivatives and/or their salts.

With regard to the oils which are contained inter alia as cosmeticactive ingredient in the inventive composition, in particular cuckooflower oil, avocado oil, coconut oil, jojoba oil, wheat germ oil,macadamia nut oil, apricot kernel oil, hempseed oil, linseed oil, sesameoil, sunflower oil, groundnut oil, rosemary oil, chamomile oil, sageoil, calendula oil, lavender oil, St. John's wort oil, melissa oil,sallow thorn oil, tea tree oil, cedar wood oil, cypress oil, eveningprimrose oil, red current seed oil, borage oil, rose hip oil, soya oil,fish oil, almond oil, olive oil, palm oil, safflower oil, moringa seedoil, castor oil, sweet almond oil, corn oil, canola oil, argan oil,amaranth seed oil, and/or constituents of these oils are to be named.Falling within the term constituents of these oils are, in particular,such oil fractions which are specified by a uniform and standardizedstructure, by their degree of saturation and/or the double bond number.

The concentration of oil or respectively oil constituent which iscontained as cosmetic active ingredient in the inventive composition forits cosmetic application, is directed to the respective field ofapplication and varies in particular between 0.5% by weight and 40% byweight in relation to the composition ready for use.

Belonging to the previously listed organic and inorganic metal compoundswhich are contained as cosmetic active ingredients in embodiments of theinventive composition are, in particular, sodium-, potassium-,magnesium-, calcium- and zinc salt, wherein here preferably asanions-fluoride, fluoride, sulphate, phosphate, 2-aminoethylphosphate,glycolate, lactate, fumarate, in particular monomethyl- and/ormonoethylfumarate, tartrate, respectively alone or in a mixture.Furthermore, depending on the field of application, the inventivecomposition can contain natural sea salts as cosmetic active ingredient.Furthermore, as inorganic or respectively organic compound in theinventive composition, magnesium oxide, magnesium carbonate, magnesiumaluminium silicate, magnesium stearate, magnesium isostearate, talcum,calcium carbonate, zinc oxide, zinc carbonate, zinc stearate, zinclaurate, titanium dioxide, iron oxide, iron hexacyanoferrate, bismuthoxychloride, aluminium oxide, alumosilicate or silicon dioxide can bepresent, wherein as tanning agent the cosmetically approved colourantsand/or tan accelerating agents, such as in particular dihydroxyacetoneand/or erythrulose are to be named.

Instead of the previously mentioned humectants or in addition hereto,other developments of the inventive composition contain as cosmeticactive ingredients such humectants which comprise in particularphysiologically compatible polyols, such as preferably glycol, propyleneglycol, butylene glycol, pentylene glycol, hexylene glycol and/orglycerine, saccharides, such as in particular inositol, sorbitol,mannite, platinite, maltodextrin, dextrin, cyclodextrin, glucose,fructose, lactose, mannose, glactose, decylene glycol and/or octanediol.A particularly preferred humectant which is contained in the inventivecomposition as cosmetic active ingredient are ureas and ureaderivatives.

In addition to the already previously listed oils or respectively oilconstituents, furthermore fats and waxes are to be named as cosmeticactive ingredients, thus in particular rice bran wax, mono-, di-, tri-and/or polyglycerides of ricinoleic acid, of 12-hydroxystearic acidand/or or 11-hydroypalmitic acid, ricinoleic acid octyldedecylester,12-hydroxystearic acid octyl ester, beeswax, Japan wax, carnauba wax,cetyl palmitate, cocoa butter, shea butter, squalane, cholesterin,cholesteryl sulphate, phytosterols and/or lanolin, in particular lanolinalcohols or derivatives. Waxes and oils of the plant genus Peciloneuronindicum are also preferred, and in particular those which contain atleast 20% by weight lignoceric acid, and in addition synthetic andnatural mixtures of epidermal lipids, as are offered under thedesignation Skinmimics by the company Degussa and Meadowestolide by thecompany Fancor. Furthermore, depending on the field of application, ascosmetic active ingredient in the inventive composition vitamins and/orprovitamins can be contained, in particular vitamin A, vitaminB-complex, vitamin C, vitamin E and vitamin D and/or derivativesthereof, such as in particular vitamin A acid, vitamin A acetate,vitamin A palmitate, vitamin C palmitate, vitamin E acetate, vitamin Epalmitate and/or vitamin E linoleate, alfacalcidol, calcitriol,colecalciferol, ergocalciferol, transcalcifediol, calciprotriol,calcifediol, vitamin D₃, β-carotene, panthenol, pantothenic acid, biotinor also antipruritic surface anaesthetics, thus in particular lidocaine,benzocaine, polidocanol, aqueous urea solutions, isoprenalin,cortamiton, quinisocaine, antipruritic H₁ antihistamines, thus inparticular meclozine, cetirizine, promethazine, diphenhydramine,clophenoxamine, doxylamine, pheniramine, dexchlorpheniramine, bamipine,clemastine, dimetidene, mebhydroline, loratadine, oxatomide, terfenadineand/or astemizol. With regard to the glucan derivatives, in particularcarboxymethylglucan or carboxymethylglucan are to be named.

A particularly suitable further development of the inventive compositionwhich has in particular a soothing cosmetic active ingredient makesprovision that this active ingredient, which of course can also be anactive ingredient mixture, is selected from the group which comprisesshea butter, ceramids, in particular ceramide-1, ceramide-3, ceramide-6and/or ceramide-7, cupuacu butter, squalan and/or triglycerides, inparticular middle-chain, saturated C₈-C₂₄-triglycerides. This furtherdevelopment of the inventive composition is particularly suited tostrengthen, develop and build up the intercellular lipids of the skinand to increase the acid coat and the amount of sebum and hence to bringabout an increased protection of the skin.

In order to treat in particular infected, irritated or diseased areas ofthe skin, thus for example eczema, burns, preferably of the 1^(st) and2^(nd) degree, bedsores or abscesses with the inventive composition, orto effectively protect the skin from such diseases, a furtherdevelopment of the inventive composition makes provision that hereinalternatively or in addition to the previously mentioned activeingredients, in particular the previously mentioned cosmetic activeingredients, at least one anti-inflammatory active ingredient iscontained, which is selected from the group which comprises ursolicacid, soya sterol, 18-beta-glycyrrhetic acid, gamma oryzanol, ferulicacid, avenanthramides and derivatives of the previously mentionedanti-inflammatory active ingredients.

In particular in such an embodiment of the inventive composition, theactive ingredient is present in a concentration between 0.001% by weightand 35% by weight, preferably in a concentration between 0.1% by weightand 15% by weight in relation to the composition ready for use, whereinthese concentration data preferably refer to the cosmetic activeingredients which have been previously mentioned and are also listedbelow. Such developments of the inventive composition which are appliedpharmaceutically and contain the pharmaceutical active ingredientsmentioned in the introduction and the previously listedanti-inflammatory active ingredient have active ingredientconcentrations which vary in particular between 0.01% by weight and 5%by weight and preferably between 0.1% by weight and 2.5% by weight inrelation to the composition ready for use.

All the plant oils or plant extracts previously listed as cosmeticactive ingredients can also be replaced by corresponding plant parts,thus in particular roots, seeds or flowers, in so far as these plantparts are correspondingly dried and communicated, in particularpulverized.

Belonging to the preferred further cosmetic active ingredients, at leastone of which must be contained in the inventive composition, are the“anti-ageing” active ingredients on the basis of the previouslymentioned peptides and proteins, metal proteinase inhibitors, senescenceretardants, thus in particular geranylgeraniol, and niacinamide, skinregeneration promoting active ingredients, such as in particularretinol, retinol derivatives, yeast extracts, panthenol, allantoin, DNArepair-promoting substances, such as in particular T 4 endonuclease Venzymes, other enzymes, such as e.g. Zonase (manufacturer: Wasser BioTechnologie), further barrier-assisting active ingredients, such aspreferably calcium compounds, in particular calcium pantothenate,hydroxyapatite and its mixtures, sodium beta sitosterol sulphate,glycyrrhetic acid compounds, bisabolol, anti-irritants, such asantifreeze proteins, thus e.g. AAGP™ (manufacturer: Protokinetix),chitosan, skin whitening agents, such as e.g. arbutin, anticelluliteactive ingredients, in particular caffeine, active ingredients for scartreatment, such as e.g. panthenol, urea, heparin and/or special plantextracts, deodorants/antiperspirants, thus e.g. aluminium chlorohydrate,aluminium-zirconium chlorohydrate, perfumes, mouth care agents, such ase.g. chlorhexidingluconate, hair treatment, in particular finasteride,aminexil, ketoconazol, foot care agents, such as e.g. urea and/orsalicylic acid, hand care agents and/or baby care agents, such as e.g.allantoin and/or panthenol, agents for reducing or slowing the growth ofunwanted body hair, such as e.g. eflornithine, shaving aids, and activeingredients for the treatment of unclean greasy skin and the accessorysymptoms connected therewith, antibacterially-acting and/orsebum-inhibiting active ingredients, such as in particular salicylicacid and/or Acnacidol (manufacturer: Vincience).

A further particularly suitable embodiment of the inventive compositionmakes provision that here, as at least one active ingredient, it hassuch an active ingredient which is selected from the group consisting oficaridin, clove oil, citronellal, cedar wood oil, lavel oil, cinnamonoil, permethrin and crotamiton. These embodiments of the inventivecomposition serve here focussed on the prophylaxis of insect bites, inparticular bites by gnats, fleas, lice and/or ticks.

Basically, it is to be recorded that the inventive composition containsas carrier substance, which forms with the outer phase, and inparticular with water, the previously described particular structure,contains such carrier substances which simultaneously have a hydrophilicand a hydrophobic molecule moiety. In particular such carrier substancesare preferably to be named here which are selected from the group whichcomprises monoglycerides, diglycerides, triglycerides, preferably alsodistilled middle-chain monoglycerides, sphingolipids,phosphatidylcholine, phospholipids, fatty alcohols, fatty acids andderivatives of the previously mentioned compounds, wherein the fattyacids and fatty alcohols preferably have a C₈-C₂₄-saturated linearcarbon chain.

However, it is particularly suitable if in the inventive composition ascarrier substance which is able to form the particular structure whichhas previously been described several times at least one hydrogenatedlecithin and/or a hydrogenated phospholipid, and in particular ahydrogenated phosphatidylcholine is contained. Here, in fact, is wasable to be established that such hydrogenated phospholipids and inparticular the hydrogenated phosphatidylcholine on the one hand forms toa high degree with the outer phase these particular structures which arespecific to the inventive composition and characterize it, and which onthe other hand are excellently suited to migrate into the intercellularlipids of the skin and in particular into the intercellular lipids ofthe corneal layer and to assist there the build-up or respectivelydevelopment of this intercellular lipid layer, as has been describedrepeatedly above. In addition, the hydrogenated lecithins and inparticular the hydrogenated phosphatidylcholine have the furtheradvantage that they form particularly stable compositions which on theone hand are resistant with respect to chemical and in particularoxidative attack, and on the other hand have a high physical stabilityand hence an extremely great storage stability. Active ingredientsembedded within this structure are accordingly very effectivelyprotected against decomposition.

However, such a hydrogenated lecithin or respectively such ahydrogenated phospholipid and in particular such a hydrogenatedphosphatidylcholine are preferably provided in the inventive compositionin which all acyl radicals are exclusively or predominantly saturated,so that in particular only unsaturated acyl radicals in a concentrationof less than 10% by weight and preferably less than 5% by weight andmost preferably less than 1.5% by weight are present in the hydrogenatedlecithin, the hydrogenated phospholipid and/or in particular in thehydrogenated phosphatidylcholine.

By way of clarification, it is to be noted that the term phospholipid ofcourse covers not only a single phospholipid but also a mixture ofphospholipids, wherein the phospholipid or respectively the phospholipidmixture can be or natural or synthetic origin. It is likewiseself-evident that the phospholipid can be hydrogenated not only in theabove sense, but that instead of this hydrogenated phospholipid asynthetic phospholipid is used, in which the acyl radicals are all orpredominantly saturated in the above sense.

The advantages described above are possessed to an increased extent bysuch further developments of the inventive composition which contain ascarrier substance a hydrogenated phospholipid which has at least 60% byweight and preferably between 70% by weight and 95% by weighthydrogenated phosphatidylcholine, wherein this concentration data refersto the concentration of the hydrogenated phospholipid which is containedas such as carrier substance in the inventive composition ready for use.

With regard to the concentration of the carrier substance contained inthe inventive composition, which forms the structure which is particularto the inventive composition, it is to be generally recorded that thisconcentration is directed to the purpose for which the inventivecomposition is applied and to which active ingredient it contains.Furthermore, the concentration of the carrier substance is directed tothe chemical nature of the respectively selected carrier substance andin addition to which concentration of double membrane layers is to becontained within the inventive composition. In particular, the at leastone carrier substance is present in the inventive composition in aconcentration between 0.5% by weight and 30% by weight, preferably in aconcentration between 0.7% by weight and 5% by weight in relation to thecomposition ready for use.

In particular when the previously described hydrogenated phospholipid,the hydrogenated phosphatidylcholine or respectively the hydrogenatedlecithin or a correspondingly synthetically produced phospholipid withcorresponding saturated acyl radicals has a phase transition temperatureover 30° C. and under 70° C., with the use of such a carrier substancesuch embodiments of the inventive composition can be providedparticularly simply which have the desired particular structure whichwas described extensively in the introduction. The phase transitiontemperature is defined here such that it designates the temperature atwhich the crystalline system of the carrier substance transfers into aliquid system of the carrier substance, wherein in many cases thistemperature does not represent an actual individual temperature, butrather is characterized by a temperature range. Thus, for example, thephase transition temperature for the particularly preferred hydrogenatedphosphatidylcholine which is isolated from soya beans and which has aphosphatidylcholine concentration of 93±3% by weight and the acylradicals of which consist at 85% by weight of stearic acid and at 14% byweight of palmitic acid, lies between 54° C. and 58° C. and is inparticular 56° C.

As has already been previously described, a particular preferredembodiment of the inventive composition makes provision that the latterhas water as inner and outer phase. Depending on the application, theconcentration of the water varies in the inventive composition between5% by weight and 90% by weight in relation to the weight of thecomposition ready for use, wherein these concentrations also preferablyapply to other liquids which form the inner and/or outer phase.

Depending on the respectively intended field of application and therespectively selected carrier substance and the active ingredient whichis respectively to be used, an advantageous further development of theinventive composition makes provision that the latter has at least onealcohol, in particular a polyvalent alcohol, wherein of course suchalcohols are selected here as alcohols which do not cause any or only anextremely mild skin irritation.

Pentylene glycol, caprylyl glycol, phenylethyl alcohol, decylene glycol,glycerine or mixtures of the previously mentioned alcohols have provento be particularly suitable alcohols, so that accordingly these alcoholsand in particular the previously described triple mixture of pentyleneglycol, caprylyl glycol and glycerine are contained in the inventivecomposition.

A further advantageous development of the inventive composition makesprovision that the latter contains, in addition to the previouslymentioned active ingredients, or alternatively thereto, also at leastone N-acyl alkanolamine and preferably N-acyl ethanolamine, wherein thisN-acyl alkanolamine is known for having anti-inflammatorycharacteristics. The concentration of the N-acyl alkanolamine and inparticular of the N-acyl ethanolamine varies here between 0.01% byweight and 10% by weight, preferably between 0.1% and 3%, respectivelyin relation to the weight of the composition ready for use.

Particularly when the N-acyl alkanolamine has a C₁-C₂₄ acyl radical,preferably a linearly saturated and/or unsaturated C₁-C₂₄ acyl radical,with such a further development of the inventive composition,inflammatory skin irritations or skin diseases which occur in an extrememanner can be treated particularly well, wherein in particular also skinirritations, skin excitations, erythemas and burning sensations of theskin can already be eliminated after a few applications.

In particular in the previously described embodiments of the inventivecomposition which contain N-acyl alkanolamine, this N-acyl alkanolamineis selected from the group which comprises N-acetyl ethanolamine,N-oleoyl ethanolamine, N-linolenoyl ethanolamine, N-cocoyl ethanolamineand N-palmitoyl ethanolamine, wherein these previously mentionedparticular ethanolamines are used both as individual substance and alsoas a mixture of several ethanolamines. Likewise, the inventivecomposition can comprise as N-acyl alkanolamine aN-acyl-2-hydroxy-propylamine, wherein this N-acyl-2-hydroxy-propylaminecontains in particular as acyl radical fatty acids of coconut oil and/orpalm oil. The previously listed N-acyl alkanolamines additionally causethe moisture of the skin to increase and in addition also to bestabilized at an acceptable value.

Depending on the respective nature of the application, i.e. whether theinventive composition is used e.g. as a cream, ointment, gel, lotion orbath additive, embodiments of the inventive composition which areformulated accordingly contain at least one preservative, anantioxidant, a thickener and/or a gelling agent, wherein theconcentration of these preservatives and antioxidants, which areadditionally designated summarized below as other additives, varies inparticular between 0% by weight and 10% by weight in relation to thecomposition ready for use.

If in preferred embodiments of the inventive composition a thickener ora gelling agent is present, then it lends itself here to choose asgelling agent or as thickener a natural and/or synthetic colloid and/ora natural and/or synthetic hydrocolloid, wherein it is very readilypossible that the inventive composition contains a mixture of naturaland synthetic thickener or respectively of natural and synthetic gellingagent. The concentration of these colloids or respectively hydrocolloidsusually varies between 0.1% by weight and 5% by weight, respectively inrelation to the composition ready for use.

As an example of suitable gelling agents or respectively thickeners, inparticular the starch ethers, starch esters, cellulose ethers orcellulose esters known per se, or else the derivatives of acrylic acidand/or derivatives of acrylic acid salts, in particular oligomeric andpolymeric acrylic acid or respectively acrylic acid salts or derivativesthereof are to be mentioned.

Preferred embodiments of the inventive composition have as carriersubstance respectively between 0.5% by weight and 7% by weight of ahydrogenated phosphatidylcholine, between 0.01% by weight and 5% byweight of the active ingredient and between 5% by weight and 96% byweight water as hydrophilic liquid, wherein then these preferredembodiments additionally contain between 0.5% by weight and 10% byweight cupuacu butter, between 0.5% by weight and 15% by weight sheabutter, between 0.001% by weight and 3% by weight ceramid, preferablyceramide-1, ceramide-3, ceramide-6 and/or ceramide-7, between 0.1% byweight and 5% by weight of the colloid or hydrocolloid, between 2% byweight and 42% by weight of the previously described oil and/or of thepreviously described oil component, and between 0% by weight and 10% byweight other additives.

With regard to the pH-value which the inventive composition has, it isto be recorded in particular that here a pH-value is selected whichpreferably varies between 4.0 and 7.6 and in particular between 4.8 and7.2.

As has already been pointed out several times above, an essentialcriterion of the inventive composition is that the latter has theparticular structure previously described and that furthermore the atleast one active ingredient is distributed between the double membranelayer and the layer of the inner phase as is quantified above.Particularly when the inventive composition contains between 10% byweight and 95% by weight, preferably between 30% by weight and 95% byweight the double membrane layer, wherein the previously indicatedconcentrations refer to the weight of the carrier substance contained inthe inventive composition, such a development has to a particularly highextent the advantages previously described in the inventive composition.

It is to be recorded that the inventive composition in particularcontains such a structure in which each double membrane layer has athickness between 4 nm and 20 nm, in particular between 4 nm and 8 nm,wherein furthermore the layer thickness of the inner phase, which isarranged between adjacent double membrane layers, preferably variesbetween 2 nm and 10 nm.

As already previously presented repeatedly, the inventive compositioncan be applied in any suitable form, whether for example as a cream,ointment, gel, lotion or as a bath additive.

However, it is particularly suitable if the inventive composition ispresent as a cream-like or gel-like composition and has a viscosity at20° C. between 2.000 mPas and 40.000 mPas, preferably between 12.000mPas and 25.000 mPas.

A particularly suitable development of the inventive composition makesprovision that here the composition contains such a structure whichcomprises between 2 and 15 lamellar double membrane layers arranged oneover the other in the manner of a sandwich.

The term “and/or” which is repeatedly used in the present applicationcovers both additively and also alternatively the individual elements ofa list which are thus linked, so that these elements are to beunderstood as linked selectively with “and” or respectively with “or”.Furthermore, the terms used in the singular of course also comprise theplural.

Advantageous further developments of the inventive composition areindicated in the sub-claims.

The inventive composition is explained below with the aid of fourexamples in connection with the drawings, in which:

FIG. 1 shows a diagrammatic illustration of a first embodiment of thepreviously described particular structure;

FIG. 2 shows a diagrammatic illustration of a second embodiment of thepreviously described particular structure; and

FIG. 3 shows a diagrammatic illustration of a third embodiment of thepreviously described particular structure.

In FIGS. 1 to 3, the same elements are provided with the same referencenumbers.

FIGS. 1 to 3 represent different embodiments of the structures as theyoccur in the inventive composition and are essential for the latter.

All the structures shown diagrammatically in FIGS. 1 to 3 have in commona planar first double membrane layer 1 and a planar second doublemembrane layer 2, wherein the double membrane layers 1 and 2 enclose theplanar layer of an inner phase 3 in the manner of a sandwich.

Each double membrane layer 1 or respectively 2 consists of two layers Aand B of the carrier substance, wherein within the two layers A orrespectively B the individual molecules of the carrier substance arealigned so that the outer hydrophilic radicals 4 of the upper layer A ofeach double membrane layer 1 or respectively 2 are respectively alignedoutwards to the outer hydrophilic phase which completely surrounds therespective structure, whereas the inner hydrophilic radicals 5 of thelower layer B point inwards to the layer of the inner phase 3. This hasthe result that within each layer A or respectively B the lipophilicradicals 6 of each double membrane layer 1 or respectively 2 are alignedto each other. Accordingly, in the structures shown in FIGS. 1 to 3,only the outer hydrophilic radicals 4 come in contact with the outerphase, whereas the inner hydrophilic radicals 5 of each double membranelayer 1 or respectively 2 come in contact exclusively with the layer ofthe inner phase 3.

Reference number 7 designates respectively active ingredient moleculesillustrated in dark print or respectively active ingredient aggregatesillustrated in dark print, wherein the active ingredient moleculesdiffer from the active ingredient aggregates in that active ingredientaggregates represent combinations of active ingredient molecules, whichis abbreviated below as active ingredient 7.

The diagrammatic illustrations according to FIGS. 1 to 3 differ fromeach other in that the active ingredient 7 is distributed differentlybetween the layers 1 to 3.

In FIG. 1, the predominant amount of active ingredient 7 is distributedin the double membrane layer 1 or respectively 2 and is embedded therebetween the hydrophobic radicals 6, whereas the layer of the inner phase3 has a relatively small concentration of active ingredient 7. Such acomposition which contains a predominant hydrophobic active ingredientin particular has such a structure.

In FIG. 2 the predominant amount of active ingredient 7 is embedded intothe layer of the inner phase 3, whereas the double membrane layer 1 orrespectively 2 has a relatively small concentration of active ingredient7, which is embedded between the hydrophobic radicals 6, preferably inthe immediate vicinity of the hydrophilic radicals 4 and 5. Such acomposition which contains a predominant hydrophilic active ingredientin particular has such a structure.

FIG. 3 illustrates such a structure in which the inner phase 3 containsa relatively small concentration of active ingredient 7. The concernhere is with the original active ingredient. Furthermore, FIG. 3illustrates diagrammatically such active ingredients 8 in which likewisemolecules or respectively aggregates can be concerned, which areanchored within the double membrane layer 1 or respectively 2 by meansof lipophilic compounds which are illustrated diagrammatically in FIG. 3as dark curved lines 9. In particular such a composition which containspredominantly a hydrophilic active ingredient has such a structure,wherein a portion of this active ingredient is transformed with thelipophilic compounds (anchor group) with the formation of intermolecularinteractions between lipophilic compound and active ingredient, whereasthe remaining portion contains a correspondingly non-transformed activeingredient 7. The extent of the transformation can be determined bycoordination of the stoichiometric ratios of active ingredient andlipophilic compound. This possibility exists not only for hydrophilicactive ingredients but also for amphiphilic active ingredients.

EXAMPLE A Production of a Concentrate Containing Retinol as ActiveIngredient

A concentrate containing retinol as active ingredient was produced fromthe following ingredients:

Ingredients of Phase 1:

6% by weight phosphatidylcholine3% by weight caprylic/capric triglyceride3% by weight glycerine5% by weight pentylene glycol

Ingredient of Phase 2:

10% by weight retinol

Ingredient of Phase 3:

73% by weight water

The ingredients of Phase 1 were heated to 80° C. with uniform stirring.Then the ingredient of Phase 3 was heated to 75° C. At 80° C. theingredient of Phase 2 was added to the ingredients of Phase 1 and werestirred uniformly together. Then the ingredients of Phase 3 were addedto the ingredients of Phase 1 and 2 which had been stirred together, sothat the ingredients of all phases which were thus mixed with each otherhave been homogenized at 20,000 r/min by means of Ultra Turrax. Thepre-emulsion which was thus produced was microdispersed by means of ahigh pressure homogenizer under the following conditions: 2-5 cycles at800 bar. After cooling of the micro-dispersed mixture with uniformstirring to 30° C., homogenization was carried out again for 2 minutesat 20,000 r/min by means of Ultra Turrax.

In cosmetics, retinol is deemed to be an active ingredient which isdifficult to stabilize, which is subject to a constant oxidativedecomposition process. Classic stabilising methods such as the additionof antioxidants, encapsulating in liposomes or cyclodextrins again andagain come up against their limits, because they either do not reach thedesired active ingredient concentration or do not have the necessarystability.

In a comparative test, surprisingly it was able to be established thatthe retinol stability was distinctly increased by the describedcomposition.

For this test, a liposomal formulation containing retinol in theconcentration indicated above was compared with the previously describedconcentrate.

For this purpose, the respective sample was exposed to a lightirradiation (1.4 mW/cm2 over 20 minutes) as stress parameter. Theirradiation took place in quartz glass chambers with a water-filledcover (company: Heraeus Quarzglas GmbH), which served to absorb theinfrared energy. This was necessary, in order to prevent thevaporization of the solvent in the respective sample during theirradiation. The retinol concentration remaining after the irradiationwas carried out by separation by means of high pressure liquidchromatography (RP-18 column, mobile phase consisting of a mixturemethanol-n-hexane 72:78 (vol./vol.)) and subsequent detection of the UVabsorption at 324, 292 and 276 nm. The irradiation was carried out foreach sample three times, to thus guarantee the reproducibility.

The liposomal formulation only allowed a 30% stabilization of theretinol, so that through the irradiation 70% by weight of the originalretinol were decomposed, whereas the retinol concentration after theirradiation of the concentrate lay at 70%, so that hereby only 30% ofthe originally used active ingredient retinol was decomposed.

EXAMPLE B Production of a Concentrate Containing boswellia as ActiveIngredient Ingredients of Phase 1:

7.5% by weight hydrogenated phosphatidylcholine3% by weight caprylic/capric triglyceride3% by weight glycerine5% by weight hexylene glycol3% by weight meadow foam seed oil5% by weight Boswellia serrata extract

Ingredient of Phase 2:

73.5% by weight water

The ingredients of Phase 1 were heated to 85° C. with uniform stirring.Then the ingredients of Phase 2 were likewise heated to 85° C. and atthis temperature were added to Phase 1 and hereafter the mixed phaseswere stirred uniformly and homogenized at 24,000 r/min by means of UltraTurrax. The pre-emulsion which was produced was micro-dispersed for 4-6cycles at 750 bar by means of a high pressure homogenizer. After coolingto 35° C. the micro-dispersion was homogenized again for 2 minutes at20,000 r/min by means of Ultra Turrax. The concentrate which was thusproduced was cooled with stirring to 30° C.

Owing to its anti-inflammatory characteristics, Boswellia serrataextract is of great interest as an active ingredient for the cosmeticand pharmaceutical industry. Owing to its resin-like characteristics,however, Boswellia serrata extract is deemed to be a molecule which isdifficult to stabilize, because it considerably impairs the emulsionformation and is therefore only used in small concentrations in cosmeticor pharmaceutical products.

By a test which compares the previously described concentrate with theactive ingredient named there in the concentration listed there with aconventional Boswellia serrata extract emulsion, which corresponded tothe concentrate in its concentration of active ingredient, it was ableto be established that only the concentrate provides a stable and highlyconcentrated form of presentation for the active ingredient.

By macroscopic and microscopic analysis (microscope: Olympus CH2 ModelCHT) it was demonstrated that the typical destabilization phenomenaoccurring after storage with the conventional emulsion did not occurwith the concentrate. In particular, in contrast to the conventionalemulsion, the concentrate did not show macroscopically any decomposition(phase separation) with subsequent distinctly detectable oil separation.Furthermore, both the concentrate and also the conventional emulsionwere examined microscopically at a 400-times enlargement with regard tothe crystalline structures contained therein and the droplet sizegrowth. It was able to be established here that with the conventionalemulsion within the first 3 days after production (storage at 23±2° C.)a distinct particle size growth and a morphological change in the lipiddroplet form to amorphous, non-symmetrical structures occurred, which isjudged among specialists as a sure sign of an incipient phase separationwhich is also able to be established macroscopically.

In contrast to this, with the concentrate a change was not able to beestablished either macroscopically or microscopically, so that theconcentrate remained stable and unchanged even in excess of months.

EXAMPLE C Production of a Concentrate Containing Proline as ActiveIngredient Ingredients of Phase 1:

6% by weight hydrogenated phosphatidylcholine7% by weight jojoba oil3% by weight glycerine5% by weight pentylene glycol3% by weight Butyrospermum parkii

Ingredient of Phase 2:

15% by weight Proline

Ingredient of Phase 3:

61% by weight water

The ingredients of Phase 1 were heated to 80° C. with uniform stirring.At 80° C. the ingredient of Phase 2 was added to the mixed Phase 1 andstirred uniformly. Hereafter the Phase 3, heated to 75° C. was added tothe ingredients of Phases 1 and 2, which were mixed together, and thiswas homogenized at 20,000 r/min by means of Ultra Turrax. Thepre-emulsion which was thus produced was micro-dispersed for 2-5 cyclesat 800 bar by means of a high pressure homogenizer. After cooling to 30°C. with uniform stirring, the mixture which was thus produced washomogenized for 2 minutes at 20,000 r/min by means of Ultra Turrax.

In this example the proline serves as model substance for anosmoprotectant.

In a test which on the one hand comprises a conventional oil-in-wateremulsion which contained the same concentration of proline and on theother hand the previously described concentrate, by way of comparisonthe proline concentration present in the upper layer of the skin wasdetermined after application of the respective product.

After application of the respective sample and after a 60-minute periodof dwell had elapsed, 10 adhesive tape tear-offs were taken from thesame skin area by the stripping method. For the comparative test, carewas taken that skin areas of identical size were treated with identicalquantities of the concentrate or respectively of the oil-in-wateremulsion. The corresponding adhesive tape strips were extractedrespectively with 1 ml methanol. The concentration of proline wasdetermined by means of high pressure liquid chromatography (CROWNPAK CR(+) column, mobile phase consisting of a HCLO4 solution, pre-columnderivatization with DABS-CL (CrestPak C18S column, mobile phase: 8 mMsodium dihydrogenphosphate dihydrate in H2O with 4% DMF, detection ofthe UV absorption at 280 nm), wherein all the values were established asa triple determination.

As a result, it is to be recorded that the proline concentrationdetermined in the skin after application of the concentrate was higherby 50% than the proline concentration which was measured afterapplication of the oil-in-water emulsion.

EXAMPLE D Production of a Concentrate Containing PalmitoylPentapeptide-3 as Active Ingredient Ingredients of Phase 1:

8% by weight hydrogenated phosphatidylcholine11% by weight isopropyl palmitate3% by weight glycerine10% by weight ethanol

Ingredient of Phase 2:

0.3% by weight palmitoyl pentapeptide-3

Ingredient of Phase 3:

67.7% by weight water

The ingredients of Phase 1 were heated to 80° C. with uniform stirring.At 80° C. the ingredient of Phase 2 was added to Phase 1 and stirreduniformly. The ingredient of Phase 3, heated to 75° C. was added to theingredients of Phases 1 and 2 and homogenized at 20,000 r/min by meansof Ultra Turrax. The produced pre-emulsion was micro-dispersed for 2-5cycles at 800 bar by means of a high pressure homogenizer and was thencooled with uniform stirring to 30° C. This was followed by a furtherhomogenizing for 2 minutes at 20,000 r/min by means of Ultra Turrax.

Palmitoyl pentapeptides-3 have been in the centre ofdermatological/cosmetic interest for years. In a similar manner tocopper peptides, palmitoyl pentapeptides stimulate the wound healingprocesses in the deeper layers of the skin by production of collagen andfibronectin. Thereby, skin ageing is actively counteracted and woundhealing processes are actively assisted, with the effect frequently onlyoccurring in periods of 4 to 6 weeks.

According to the previously described method, the previously describedconcentrate was examined by comparison with a conventional formulation,wherein the previously described test conditions were applied. Afterthis, it was able to be established that the penetration amount ofpalmitoyl pentapeptide-3 with the application of the concentrate was 40%higher compared with the conventional formulation.

The concentrates produced according to examples A to D can be processedto a product ready for use by dilution in a ratio of between 5 to 50% byweight concentrate with 95 to 50% by weight additives, thus for examplewater, thickeners, hydrogels or further cosmetic active ingredients.

EXAMPLE E Production of a Final Formulation with the Active IngredientHexapeptide-9 Ingredients of Phase 1:

2% by weight hydrogenated phosphatidylcholine1% by weight hexapeptide-90.8% by weight Butyrospermum parkii1.5% by weight caprylic/capric triglyceride1% by weight squalane

Ingredients of Phase 2:

1% by weight glycerine1.3% by weight pentylene glycol19% by weight water

Ingredients of Phase 3:

25% by weight caprylic/capric triglyceride0.10% by weight carbomer0.10% by weight sodium carbomer0.10% by weight xanthan gum

Ingredients of Phase 4:

3.5% by weight pentylene glycol0.35% hydroxyethylcellulosead 100.0% by weight water

The ingredients of Phase 1 were heated to 85° C. with uniform stirringuntil all the active ingredients are present in dissolved form.Likewise, Phase 2 was heated to 85° C. with stirring in a separatevessel. Phase 2 was then added to Phase 1, stirred briefly and hereafterhomogenized by means of Ultra Turrax at 24,000 r/min.

The pre-emulsion resulting herefrom was micro-dispersed by means of ahigh pressure homogenizer in 5-7 cycles, pressure 600 bar. The produceddispersion was cooled to 30° C. with uniform stirring.

Phase 3 and Phase 4 were heated in respectively separate vessels to 30°C. with uniform stirring. Phase 4 was then added to Phase 3 and thenhomogenized by Ultra Turrax (12,000 r/min). The produced dispersion wascooled to 30° C. with slight stirring. The high viscous dispersion fromPhases 1 and 2 was then added. Hereafter, the mixture was homogenized at30° C. by Ultra Turrax (12,000 r/min) until a uniform structure waspresent. The final formulation which was thus produced was able to beused directly.

EXAMPLE F Production of a Final Formulation with the UVB FilterOctocrylene and the UVA Filter Butylmethoxydibenzoylmethane Ingredientsof Phase 1:

2.10% by weight hydrogenated phosphatidylcholine3.00% by weight octocrylene2.50% by weight butylmethoxydibenzoylmethane

Ingredients of Phase 2:

1.00% by weight glycerine1.30% by weight pentylene glycol18.00% by weight water0.10% by weight caprylyl glycol

Ingredients of Phase 3:

22.00% by weight caprylic/capric triglyceride0.10% by weight carbomer0.10% by weight sodium carbomer0.10% by weight xanthan gum

Ingredients of Phase 4:

3.50% by weight pentylene glycol0.35% by weight hydroxyethylcellulosead 100.0% by weight water

The ingredients of Phase 1 were heated to 85° C. with uniform stirringuntil all the ingredients are present in dissolved form. Likewise, Phase2 was heated in a separate vessel to 85° C. with stirring. Phase 2 wasthen added to Phase 1 and hereafter was stirred by means of Ultra Turraxat 24,000 r/min until a homogeneous mixture was produced. Thepre-emulsion resulting from this was micro-dispersed by means of a highpressure homogenizer in 6-8 cycles, pressure 800 bar. The produceddispersion was cooled to 30° C. with uniform stirring.

Phase 3 and Phase 4 were heated in a separate vessel to 30° C. withuniform stirring. Phase 4 was then added to Phase 3 and hereafterstirred by Ultra Turrax (12,000 r/min) until a homogenous mixture wasproduced. With slight stirring, the produced dispersion was cooled to30° C. Then the high viscous dispersion from Phases 1 and 2 was added.The mixture was then homogenized at 30° C. by Ultra Turrax (12,000r/min) until a uniform structure was present. The final formulationwhich was thus produced was able to be used directly.

EXAMPLE G Production of a Final Formulation with the Active IngredientHypericin for the Treatment of Herpes Ingredients of Phase 1:

1.50% by weight hydrogenated phosphatidylcholine0.05% by weight hypericin3.00% by weight Butyrospermum parkii0.25% by weight squalane

Ingredients of Phase 2:

1.00% by weight glycerine3.00% by weight ethanol19.00% by weight water

Ingredients of Phase 3:

10.00% by weight Oleo europeae oil14.00% by weight Butyrospermum parkii0.10% by weight carbomer0.10% by weight sodium carbomer

Ingredients of Phase 4:

10.00% by weight ethanol8.00% by weight sorbitol0.25% by weight hydroxyethylcellulosead 100.0% by weight water

Ingredients of Phase 5:

0.20 aroma vanilla

The ingredients of Phase 1 were heated to 85° C. with uniform stirringuntil all the ingredients were present in dissolved form. Likewise,Phase 2 was heated in a separate vessel to 85° C. with stirring.Hereafter, the homogenous Phase 2 was added to Phase 1, stirred brieflyand thereafter homogenized by means of Ultra Turrax at 24,000 r/min. Thepre-emulsion resulting herefrom was micro-dispersed by means of a highpressure homogenizer in 5-7 cycles, pressure 600 bar. The produceddispersion was cooled to 30° C. with uniform stirring.

Phases 3 and 4 were heated respectively in separate vessels to 50° C.with uniform stirring. Phase 4 was then added to Phase 3 and hereafterhomogenized by Ultra Turrax (12,000 r/min). With slight stirring, theproduced dispersion was cooled to 30° C. Thereafter, Phase 5 was addedto the mixture and again briefly homogenized by Ultra Turrax (10,000r/min) until the aroma agent was worked in uniformly. The high viscousdispersion from Phases 1 and 2 was then added. Hereafter, the mixturewas homogenized at 30° C. by Ultra Turrax (12.000 r/min) until a uniformstructure was present. The final formulation which was thus produced wasable to be used directly.

EXAMPLE H Production of a Final Formulation with the Active IngredientPanthenyl Triacetate for the Treatment of Complaints of Dry Nasal MucosaIngredients of Phase 1:

1.50% by weight hydrogenated phosphatidylcholine1.00% by weight panthenyl triacetate0.80% by weight Butyrospermum parkii1.50% by weight caprylic/capric triglyceride0.20% by weight squalane

Ingredients of Phase 2:

1.00% by weight glycerine1.30% by weight pentylene glycol17.00% by weight water

Ingredients of Phase 3:

10.00% by weight caprylic/capric triglyceride8.00% by weight Butyrospermum parkii0.10% by weight carbomer0.10% by weight sodium carbomer0.10% by weight xanthan gum

Ingredients of Phase 4:

3.50% by weight pentylene glycol0.30% by weight sodium hyaluronatead 100.0% by weight water

The ingredients of Phase 1 were heated to 85° C. with uniform stirringuntil all the active ingredients were present in dissolved form.Likewise, Phase 2 was heated in a separate vessel to 85° C. withstirring. Phase 2 was then added to Phase 1, stirred briefly andhereafter homogenized by means of Ultra Turrax at 24,000 r/min. Thepre-emulsion resulting from this was micro-dispersed by means of a highpressure homogenizer in 2-4 cycles, pressure 700 bar. The produceddispersion was cooled to 30° C. with uniform stirring.

Phases 3 and 4 were heated respectively in separate vessels to 50° C.with uniform stirring. Phase 4 was then added to Phase 3 and hereafterhomogenized by Ultra Turrax (12,000 r/min). The produced dispersion wascooled to 30° C. with slight stirring. Thereafter, the high viscousdispersion from Phases 1 and 2 was added. The mixture was thenhomogenized at 30° C. by Ultra Turrax (12,000 r/min) until a uniformstructure was present. The final formulation which was thus produced wasable to be used directly.

EXAMPLE I Production of a Concentrate with the Active IngredientOctocrylene Ingredients of Phase 1:

6.00% by weight hydrogenated phosphatidylcholine20.00% by weight octocrylene1.00% by weight squalane

Ingredients of Phase 2:

4.00% by weight glycerine5.00% by weight pentylene glycolad 100.0% by weight water

The ingredients of Phase 1 were heated to 80° C. with uniform stirringuntil all the ingredients were present in dissolved form. Likewise,Phase 2 was heated to 80° C. in a separate vessel with stirring. Phase 2was then added to Phase 1, stirred briefly and hereafter homogenized bymeans of Ultra Turrax at 15,000 r/min. The pre-emulsion resultingherefrom was micro-dispersed by means of a high pressure homogenizer in5-6 cycles, pressure 800 bar. The produced dispersion is cooled to 30°C. with uniform stirring.

The concentrate which is thus produced can be easily converted into afinal formulation ready for use by corresponding dilution, preferablywith water, a hydrocolloid and/or alcohols, wherein this finalformulation is used as a light protection agent or respectively as a sunprotection agent.

EXAMPLE J Production of a Final Formulation with the Active IngredientOctocrylene, to be Used as a Light Protection Agent Ingredients of Phase1:

1.50% by weight hydrogenated phosphatidylcholine5.00% by weight octocrylene0.25% by weight squalane

Ingredients of Phase 2:

1.00% by weight glycerine1.25% by weight pentylene glycol16.00% by weight water

Ingredients of Phase 3:

15.00% by weight C12-15 alkyl benzoate8.00% by weight titanium dioxide0.10% by weight carbomer0.10% by weight sodium carbomer0.10% by weight xanthan gum

Ingredients of Phase 4:

3.90% by weight pentylene glycolad 100.0% by weight water

The ingredients of Phase 1 were heated to 80° C. with uniform stirringuntil all the components were present in dissolved form. Likewise, Phase2 was heated in a separate vessel to 80° C. with stirring. Phase 2 wasthen added to Phase 1, stirred briefly and hereafter homogenized bymeans of Ultra Turrax at 15,000 r/min. The pre-emulsion resultingherefrom was micro-dispersed by means of a high pressure homogenizer in5-6 cycles, pressure 800 bar. The produced dispersion is cooled to 30°C. with uniform stirring.

Phases 3 and 4 were heated respectively in separate vessels to 30° C.with uniform stirring. Phase 4 was then added to Phase 3 and hereafterhomogenized by Ultra Turrax (10,000 r/min). The produced dispersion wascooled to 30° C. with slight stirring. The high viscous dispersion fromPhases 1 and 2 was then added. Thereafter, the mixture was homogenizedat 30° C. by Ultra Turrax (12,000 r/min) until a uniform structure waspresent. The final formulation which was thus produced was able to beused directly.

COMPARATIVE EXAMPLE A

In order to be able to carry out a comparative determination of thelight protection factor (LPF), a conventional composition was producedwhich had the same active ingredient in the same concentration as waspreviously described in Example J. The conventional composition here hadthe following ingredients:

Ingredients of Phase 1:

1.50% by weight PEG-20 stearate5.00% by weight octocrylene0.25% by weight squalane1.00% by weight glycerine15.00% by weight C12-15 alkyl benzoate8.00% by weight titanium dioxide0.10% by weight carbomer0.10% by weight sodium carbomer

Ingredients of Phase 2:

0.10% by weight xanthan gum4.15% by weight pentylene glycolad 100.0% by weight water

The ingredients of Phase 1 were heated to 80° C. with uniform stirringuntil all active ingredients were present in dissolved form. Likewise,phase 2 was heated in a separate vessel to 80° C. with stirring. Phase 2was then added to Phase 1, stirred briefly and hereafter homogenized bymeans of Ultra Turrax at 15,000 r/min. The produced dispersion wascooled to 30° C. with slight stirring. Thereafter, the mixture washomogenized at 30° C. by Ultra Turrax (15000 r/min) until a uniformstructure was present.

EXAMPLE K Production of a Final Formulation with the Active IngredientIcaridin, for Use Against Ticks Ingredients of Phase 1:

3.00% by weight hydrogenated phosphatidylcholine10.00% by weight icaridin

Ingredients of Phase 2:

1.80% by weight pentylene glycol19.00% by weight water

Ingredients of Phase 3:

5.00% by weight caprylic/capric triglyceride0.10% by weight carbomer0.10% by weight sodium carbomer0.10% by weight dehydroxanthan gum

Ingredients of Phase 4:

3.50% by weight pentylene glycolad 100.0% by weight water

The ingredients of Phase 1 were heated to 80° C. with uniform stirringuntil all the ingredients were present in dissolved form. Likewise,Phase 2 was heated to 80° C. in a separate vessel with stirring. Phase 2was then added to Phase 1, stirred briefly and hereafter homogenized bymeans of Ultra Turrax at 18,000 r/min. The pre-emulsion resultingherefrom was micro-dispersed by means of a high pressure homogenizer in2-3 cycles, pressure 600 bar. The produced dispersion was cooled to 30°C. with uniform stirring.

Phases 3 and 4 were heated to 30° C. respectively in separate vesselswith uniform stirring. Phase 4 was then added to Phase 3 and homogenizedby Ultra Turrax (12,000 r/min). The produced dispersion was cooled to30° C. with slight stirring. Thereafter, the high viscous dispersionfrom Phases 1 and 2 was added. The mixture was then homogenized at 30°C. by Ultra Turrax (11,000 r/min) until a uniform structure was present.The final formulation which was thus produced was able to be useddirectly.

COMPARATIVE EXAMPLE B

In order to be able to carry out a comparative determination of theeffectiveness of the previously described composition according toExample K against ticks, a conventional composition was produced which,like Example K, had the same active ingredient in the sameconcentration.

Ingredients of Phase 1:

3.00% by weight polyglyceryl-3 polyricenoleate10.00% by weight icaridin5.00% by weight caprylic/capric triglyceride0.10% by weight carbomer0.10% by weight sodium carbomer0.10% by weight dehydroxanthan gum

Ingredients of Phase 2:

5.00% by weight pentylene glycolad 100.0% by weight water

For the production of this conventional cream-like composition, theingredients of Phase 1 were heated to 80° C. with uniform stirring untilall the ingredients were present in dissolved form. Likewise, Phase 2was heated to 80° C. in a separate vessel with stirring. Phase 2 wasthen added to Phase 1, stirred briefly and hereafter homogenized bymeans of Ultra Turrax at 18,000 r/min. The produced dispersion wascooled to 30° C. with slight stirring. The mixture was then homogenizedat 30° C. by Ultra Turrax (12,000 r/min) until a uniform cream-likestructure was present.

EXAMPLE L Production of a Final Formulation with the Active IngredientPermethrin, for Use Against Lice Ingredients of Phase 1:

2.00% by weight hydrogenated phosphatidylcholine0.40% by weight Permethrin

Ingredients of Phase 2:

1.80% by weight pentylene Glycol19.00% by weight water

Ingredients of Phase 3:

5.00% by weight caprylic/capric triglyceride0.06% by weight carbomer0.06% by weight sodium carbomer0.05% by weight dehydroxanthan gum

Ingredients of Phase 4:

3.50% by weight pentylene glycolad 100.0% by weight water

The ingredients of Phase 1 were heated to 80° C. with uniform stirringuntil all the active ingredients were present in dissolved form.Likewise, Phase 2 was heated to 80° C. in a separate vessel withstirring. Phase 2 was then added to Phase 1, stirred briefly andhereafter homogenized by means of Ultra Turrax at 9,000 r/min. Thepre-emulsion resulting herefrom was micro-dispersed by means of a highpressure homogenizer in 3-5 cycles, pressure 800 bar. The produceddispersion was cooled to 30° C. with uniform stirring.

Phases 3 and 4 were heated to 30° C. respectively in separate vesselswith uniform stirring. Phase 4 was then added to Phase 3 and homogenizedby Ultra Turrax (9,000 r/min). The produced dispersion was cooled to 30°C. with slight stirring. Thereafter, the high viscous dispersion fromPhases 1 and 2 was added. Hereafter, the mixture was homogenized at 30°C. by Ultra Turrax (9,000 r/min) until a uniform structure was present.The final formulation which was thus produced was able to be useddirectly.

EXAMPLE M Production of a Final Formulation with the Active IngredientVitamin K, for Use with Rosacea Ingredients of Phase 1:

1.50% by weight hydrogenated phosphatidylcholine5.00% by weight vitamin K0.20% by weight squalane0.10% by weight rice bran wax1.00% by weight caprylic/capric triglyceride0.25% by weight phenylethyl alcohol

Ingredients of Phase 2:

18.00% by weight water

Ingredients of Phase 3:

5.00% by weight caprylic/capric triglyceride0.10% by weight carbomer0.10% by weight sodium carbomer0.20% by weight hydroethyl cellulose

Ingredients of Phase 4:

3.50% by weight pentylene glycolad 100.0% by weight water

The ingredients of Phase 1 were heated to 75° C. with uniform stirringuntil all the ingredients were present in dissolved form. Likewise,Phase 2 was heated to 75° C. in a separate vessel with stirring. Phase 2was then added to Phase 1, stirred briefly and hereafter homogenized bymeans of Ultra Turrax at 15,000 r/min. The pre-emulsion resultingherefrom was micro-dispersed by means of a high pressure homogenizer in3-4 cycles, pressure 800 bar. The produced dispersion was cooled to 30°C. with uniform stirring.

Phases 3 and 4 were heated to 30° C. respectively in separate vesselswith uniform stirring. Phase 4 was then added to Phase 3 and hereafterhomogenized by Ultra Turrax (12,000 r/min). The produced dispersion wascooled to 30° C. with slight stirring. Thereafter, the high viscousdispersion from Phases 1 and 2 was added. The mixture was thenhomogenized at 30° C. by Ultra Turrax (10,000 r/min) until a uniformstructure was present. The final formulation which was thus produced wasable to be used directly.

Evidence of the Effectiveness of the Final Formulation Described inExample G in a Case of Herpes

10 subjects (6 female, 4 male) aged between 25 years and 55 years, whohad all suffered for at least two years from irregularly occurringherpes infections, particularly in the region of the lips and beneaththe nose, were treated with the final formulation according to Example Gat the peak level of the herpes infection. All subjects complained onthe one hand of an intense itching and on the other hand of pain.

In a first series of tests, the subjects were treated with aconventional ointment which contained the active ingredient hypericin inthe concentration corresponding to Example G. The number of dailyapplications of the conventional ointment was left to the subjectsthemselves.

Before the start of the application, after two days, after four days andafter eight days, the extent of the herpes attack and of the accessorysymptoms connected therewith was determined and noted by subjectiveassessment. The following grading was used as a basis for this:

0=no detectable case of herpes1=just still detectable case of herpes2=slight case of herpes3=medium case of herpes4=intense case of herpes5=very intense case of herpes

Furthermore, the time up to healing of the acute case of herpes wasdetermined in days, wherein at least a Grade 1 had to be given for this.

The result of this first series of tests is reproduced in the followingtable.

Conventional ointment containing hypericin healing Subject before after2 after 4 after 8 after No./Sex start days days days days  1/m 5 5 4 320  2/m 5 4 3 2 17  3/m 5 5 4 3 24  4/m 4 4 3 2 14  5/f 4 4 3 2 8  6/f 32 3 2 7  7/f 5 5 4 2 10  8/f 4 4 3 2 7  9/f 5 4 3 1 5 10/f 5 4 4 3 21

The previously selected subjects were then engaged for a second seriesof tests when they were suffering again from an acute case of herpes.The time varied here between the first series of tests and the secondseries of tests, depending on the subject, between three months and ninemonths.

In the second series of tests, the subjects were treated with thecomposition specified in Example G, with it being left to the subjectsthemselves to determine the number of daily applications of thecomposition according to Example G.

The evaluation of this second series of tests took place in an analogousmanner to the evaluation of the first series of tests and is reproducedin the following table. It is to be noted here that the subject No. ofthe first series of tests is identical to the subject No. of the secondseries of tests.

Composition According to Example G

Healing Subject before after 2 after 4 after 8 after No./Sex start daysdays days days  1/m 5 4 3 1 10  2/m 5 3 2 1 8  3/m 4 3 3 1 8  4/m 5 3 21 6  5/f 4 3 2 1 5  6/f 4 3 2 0 0  7/f 5 4 3 1 3  8/f 5 4 2 0 0  9/f 4 32 0 0 10/f 4 2 2 1 2

The comparison of the previously reproduced two tables clearly provesthe superiority of the composition according to Example G compared withthe conventional ointment. In particular, all the subjects reportedconsistently that in particular already after a few applications theitching and the pain distinctly abated, which was not the case with theconventional ointment.

Determining the Light Protection Factor of the Composition According toExample J

The COLIPA light protection factor test method was used to determine thelight protection factor. This method is a laboratory method whichrequires an artificial ultraviolet (UV) light source with defined, knownoutput. On carrying it out, a graduated series of delayed UV erythemareactions is induced on several small areas of the skin of selectedsubjects.

The subjects must present themselves at the test laboratory at leasttwice: On the first occasion they are exposed to the required UV doses,on the second occasion the delay of erythema reactions brought about bysun protection products is assessed with an identical test set-up. Bythe gradual increase of the UV dose, different degrees of skin erythema(reddening as a result of a superficial vasodilation) are produced,which reach a maximum value approximately 24 hours after the UVexposure. The exposure time which brings about an erythema onunprotected skin type II and III according to Fitzpatrick is generallyapproximately two minutes. The lowest dose which produces a distinctarea of erythema is the minimum erythema dose or MED. The MED forunprotected skin (MEDu; u stands for “unprotected”) and the MED afterapplication of a sun protection agent (i.e. the MED for protectedskin=MEDp; p stands for “protected”) are determined simultaneously onthe same subject. The MEDu and the MEDp can be evaluated visually bytrained evaluators or instrumentally with a colorimeter. Severalpreparations can be tested here simultaneously on the same subject. Thelight protection factor of the preparation is calculated for eachsubject on the basis of the ratio of MEDp to MEDu. A preparation must betested on at least 10 subjects. The confidence limits for the averagelight protection factor are to lie +/−20% within the mean value, i.e.when the mean light protection factor is 10, the calculated confidencelimits should lie above 8 or respectively below 12. If this is not thecase, tests must be carried out on further subjects until thestatistical criteria are met or 20 subjects have been used. The meanlight protection factor of a preparation is calculated from the resultsof all subjects.

The COLIPA light protection factor test method furthermore describes astandardized method for the application and distribution of the sunprotection agents onto the test surfaces, because this phase of thetesting was identified as a substantial source of experimental errors.In all tests, in accordance with the expected light protection factor ofthe test formulations a standard preparation is to be used according toCOLIPA with a correspondingly high or low light protection factor.

An examination of the test area is carried out on the subjects from thelower line of the shoulder blades down to waist height. Evidence ofsunburn, suntan, scars, skin lesions and irregular pigmentation isdetermined on the back of each subject. If, in the opinion of theexaminer, one of the listed artefacts is present in a significantmanner, the subject is excluded from the study. The examination wascarried out on 20 subjects.

Classification of Skin Types According to Fitzpatrick

The skin types are classified as follows

Skin type I tanning: never, sunburn: alwaysSkin type II tanning: slight, sunburn: alwaysSkin type III tanning: moderate, sunburn: rare

As UV source in the Solar Light Company's 601-300 Multiport Simulator,the spectrum of a xenon arc lamp is displayed through special filtersonto the erythemally effective range (COLIPA spectrum) and applied ontothe skin. The simulator is equipped with 6 irradiation fields which canemit different irradiation doses simultaneously. Through an individualtime- or output-controlled closure mechanism, different UV doses can beadministered and thus a “light graduation” can be determined. The LPF isdetermined by measurement of a product field (e.g. sun cream) and anempty field (unprotected skin). The irradiation can be carried out by arotatable ray output both sitting and lying.

In order to establish the innate reactivity of each subject to UVradiation, a series of UV irradiations are carried out 24 hours beforethe actual examination. Each irradiation field is 1 cm in diameter. Thetime intervals are selected as a geometric series, wherein theirradiation duration is extended by 25% with each field. The irradiatedareas are assessed 16-24 hours after UV exposure and the MEDu (MED ofthe unprotected skin) is determined. The MED (minimum erythema dose)serves as an indicator for the dose to be applied for the lightprotection factor examination (LPF examination). The MED is defined asthe irradiation energy which is required in order to produce a weak, butclearly discernible reddening of the skin with sharp delimitation. Theirradiation dose in this examination was detected chronologically.

The LPF for the composition according to Example J was determinedcompared with the LPF of the composition according to Example A atdistinct positions on the backs of the subjects (n=20). The determiningof the positions was carried out as follows:

-   -   Marking of the entire test area    -   Marking of the individual test areas at 35 cm², respectively for        the previously mentioned two examples which are to be compared.

The respective composition (Example J or Comparative Example A) isapplied onto each test field in a quantity of 2 mg/cm²±0.02. After theapplication, an interval of approximately 15 min is waited as the actiontime before the UV irradiation.

After the action time has elapsed, firstly an unprotected area on thesubject's back is irradiated. Then the test is repeated on the areastreated with the respective composition.

The same test is repeated on a second test area 2 h after application ofthe product. The test fields are treated with a series of UV irradiationunits of different intensity. The actual exposure time is selected bymeans of the previously determined MED of the test person and of theassumed LPF of the product. More precisely, the MED is multiplied by theassumed LPF of the product; the exposure time results from this. A 25%geometric series is selected as UV dose. After completion of theirradiation, the position of the test fields is marked. Each subject isrequested to cover the entire test area, to protect against further UVirradiation.

The evaluation of the treated and irradiated test fields was carried outby trained personnel 20-24 hours after UV exposure. The individual andaveraged LPF values for the composition according to Example J and thecomposition according to Comparative Example A are indicated in thefollowing table.

Irradiation after Example sun action Mean value Standard examined sampletime of of the LPF deviation Example J  15 min. 23.6 2.3 Example J 120min. 21.2 4.6 Comparative Example A  15 min. 13.7 4.5 ComparativeExample A 120 min. 9.8 5.9

In connection with the measurement which is carried out, it is also tobe mentioned that the high light protection factor of the compositionaccording to Example J was even still present after an action time of120 minutes, which was not the case with the composition according toComparative Example A. It can be concluded from this that owing to theparticular structure of the composition according to Example J, thelatter is positioned in a stable manner in the stratum corneum, whichwas not the case with the composition according to Comparative ExampleA. Here, the LPF decreased drastically from 13.7 to 9.8.

Evidence of the Effectiveness of the Final Formulation Described inExample K for the Prevention of Tick Contamination

In order to test the effectiveness of the composition according toExample K compared with the conventional composition according toComparative Example B, a live narcotized domestic pig of the genus susscrofa domestica (age 2½ years) was shaved fully on its left side andrespectively on its right side. The two sides of the pig were delimitedfrom each other along the spine by a 3 cm wide double-sided adhesivetape, in order to thus prevent a migration of the ticks from one side ofthe pig to the other side of the pig. The remaining margins of the sidesof the pig were likewise provided with this adhesive tape.

After fixing the anaesthetized pig in position in an upright position,the composition according to Example K was applied onto one side of thepig (measurement area approximately 500 cm²) and the compositionaccording to Comparative Example B was applied onto the other side ofthe pig (measurement area approximately 500 cm²) respectively in aconcentration of 1 g/10 cm² and was rubbed uniformly over themeasurement areas. After an action time of 10 minutes, each side of thepig was colonized by a tick population of identical stage of developmentand of identical number of ticks (respectively 20 ticks).

After a period of four hours after colonization, the number of ticks oneach side of the pig was established. A differentiation was made here asto how many ticks had attached themselves firmly and how many ticksstill colonized the respective side of the pig without a bite. Inaddition, the migrated ticks which were fixed in the adhesive strip werecounted. In addition, an examination was carried out microscopically asto whether the ticks were still alive after four hours.

The results of this investigation are reproduced in the following table:

Composition Composition according to according to Comparative Example KExample B Initial tick number 20 20 Tick number without 6 1 bite Ticknumber with bite 8 16 Migrated ticks 6 3 Dead ticks (total) 16 8

The comparison of the previously reproduced tables clearly proves thesuperiority of the composition according to Example K compared with theconventional composition according to Comparative Example B. Inparticular, the fact that only eight ticks have anchored themselves inthe skin and that a substantially higher number of dead ticks were ableto be found, prove that the composition according to Example K is highlyeffective.

With regard to the hydrogenated phosphatidylcholines used in Examples Ato M, it is to be recorded that these have a concentration ofhydrogenated phosphatidylcholine of 93±3% by weight and that the acylradicals consist of 85% by weight stearic acid and 14% palmitic acid.

1. Cosmetic or pharmaceutical composition, to be applied topically, which has a hydrophilic outer phase, at least one cosmetic and/or pharmaceutical active ingredient and at least one carrier substance for the active ingredient, wherein the carrier substance forms such structures, which comprises at least two lamellar double membrane layers, arranged one over another in the manner of a sandwich, wherein between adjacent double membrane layers, aligned parallel to each other, a layer of an inner phase is respectively arranged, characterized in that the active ingredient is distributed in the double membrane layer and in the layer of the inner phase such that the layer of the inner phase contains the active ingredient in a concentration range between 2% by weight and 98% by weight and the double membrane layer contains the active ingredient in a concentration between 98% by weight and 2% by weight, respectively in relation to the total concentration of active ingredient, and that the outer phase has no or almost no active ingredient.
 2. Composition according to claim 1, characterized in that the inner phase contains the active ingredient in a concentration range between 15% by weight and 85% by weight, preferably in a concentration range between 25% by weight and 75% by weight, and the double membrane layer contains the active ingredient in a concentration range between 85% by weight and 15% by weight, preferably in a concentration range between 75% by weight and 25% by weight, respectively in relation to the total concentration of active ingredient.
 3. Composition according to claim 1, characterized in that the concentration of the active ingredient in the inner phase and in the double membrane layer is different.
 4. Composition according to claim 1, characterized in that the outer phase has the active ingredient in a concentration of up to a maximum of 5% by weight in relation to the total concentration of active ingredient.
 5. Composition according to claim 4, characterized in that the outer phase has the active ingredient in a concentration between 0% by weight and 2% by weight in relation to the total concentration of active ingredient.
 6. Composition according to claim 1, characterized in that the composition contains a hydrophobic active ingredient and that the active ingredient is arranged predominantly, preferably of at least 70% by weight in relation to the total concentration of active ingredient, inside the double membrane layer.
 7. Composition according to claim 6, characterized in that inside the double membrane layer the hydrophobic active ingredient is embedded in a concentration between 80% by weight and 90% by weight in relation to the total concentration of active ingredient.
 8. Composition according to claim 1, characterized in that the composition contains a hydrophilic active ingredient and that the active ingredient is arranged predominantly, preferably of at least 70% by weight in relation to the total concentration of active ingredient, inside the inner phase.
 9. Composition according to claim 6, characterized in that inside the inner phase the hydrophilic active ingredient is embedded in a concentration between 80% by weight and 90% by weight in relation to the total concentration of active ingredient.
 10. Composition according to claim 1, characterized in that the active ingredient is anchored within the composition by means of a lipophilic compound on or in the double membrane layer.
 11. Composition according to claim 10, characterized in that the lipophilic compound is embedded in the double membrane layer and the active ingredient which is anchored herewith is arranged within the inner phase.
 12. Composition according to claim 10, characterized in that the lipophilic compound fixes the active ingredient by intermolecular interactions, in particular by hydrogen bonding or by Van der Waals forces.
 13. Composition according to claim 1, characterized in that the inner phase and the outer phase are identical.
 14. Composition according to claim 1, characterized in that the inner phase and/or the outer phase are liquids.
 15. Composition according to claim 14, characterized in that the inner phase and the outer phase are respectively a liquid, in particular water.
 16. Composition according to claim 1, characterized in that the composition contains as active ingredient at least one locally or systemically acting active ingredient.
 17. Composition according to claim 16, characterized in that the active ingredient is a pharmaceutical active ingredient and is selected from the group which comprises analgesics, antirheumatics, antiallergics, antibiotics, antimycotics, antiphlogistics, balneotherapeutics, corticoid active ingredients, antiseptics, circulation-enhancing active ingredients, sedatives, anaesthetics, spasmolytics and wound treatment agents, respectively alone or in a mixture.
 18. Composition according to claim 1, characterized in that the active ingredient is a cosmetic active ingredient and is selected from the group which comprises oils, fats, waxes, antioxidants, peptides, proteins, amino acids, derivatives of amino acids, light-protective filters, tanning agents, vitamins, provitamins, fruit acids, humectants, parts of plants and plant extracts, urea, glucans, glucan derivatives, organic metal compounds and inorganic metal compounds.
 19. Composition according to claim 18, characterized in that the composition has as an oil cuckoo flower oil, avocado oil, coconut oil, jojoba oil, wheat germ oil, macadamia nut oil, apricot kernel oil, hempseed oil, linseed oil, sesame oil, sunflower oil, groundnut oil, rosemary oil, chamomile oil, sage oil, calendula oil, lavender oil, St. John's wort oil, melissa oil, sallow thorn oil, tea tree oil, cedar wood oil, cypress oil, evening primrose oil, red currant seed oil, borage oil, rose hip oil, soya oil, fish oil, almond oil, olive oil and/or constituents of these oils.
 20. Composition according to claim 18, characterized in that the oil or respectively the oil constituent is present in the composition in a concentration between 0.5% by weight and 40% by weight in relation to the composition ready for use.
 21. Composition according to claim 1, characterized in that the composition contains as soothing cosmetic active ingredients shea butter, ceramids, in particular ceramide-3, cupuacu butter, squalan and/or triglycerides, in particular middle-chain saturated C8-C24-triglycerides.
 22. Composition according to claim 1, characterized in that the composition contains an anti-inflammatory active ingredient, which is selected from the group which comprises ursolic acid, soya sterol, 18-beta-glycyrrhetic acid, gamma oryzanol, ferulic acid, avenanthramides and derivatives of the previously mentioned active ingredients.
 23. Composition according to claim 1, characterized in that the composition has the active ingredient in a concentration between 0.01% by weight and 35% by weight, preferably between 0.1% by weight and 15% by weight in relation to the composition ready for use.
 24. Composition according to claim 1, characterized in that the carrier substance contained in the composition is selected from the group which comprises monoglycerides, diglycerides, triglycerides, preferably distilled middle-chain monoglycerides, sphingolipids, phosphatidylcholine, phospholipids, fatty alcohols, fatty acids and derivatives of the previously mentioned compounds.
 25. Composition according to claim 1, characterized in that the composition contains as carrier substance a hydrogenated phospholipid, in particular a hydrogenated phosphatidylcholine.
 26. Composition according to claim 25, characterized in that the hydrogenated phospholipid has at least 60% by weight hydrogenated phosphatidylcholine.
 27. Composition according to claim 1, characterized in that the composition has the carrier substance in a concentration between 0.5% by weight and 30% by weight, preferably in a concentration between 0.7% by weight and 10% by weight, in relation to the composition ready for use.
 28. Composition according to claim 25, characterized in that the hydrogenated phospholipid has a phase transition temperature over 30° C. and under 70° C.
 29. Composition according to claim 1, characterized in that the composition has the outer phase and the inner phase in a total concentration between 5% and 90% in relation to the weight of the composition ready for use.
 30. Composition according to claim 1, characterized in that the composition further contains at least one alcohol, in particular a polyvalent alcohol.
 31. Composition according to claim 30, characterized in that the composition has as alcohol phenylethyl alcohol, pentylene glycol, caprylyl glycol, decylene glycol and/or glycerine.
 32. Composition according to claim 1, characterized in that the composition has a N-acyl ethanolamine in a concentration between 0.01% by weight and 10% by weight, preferably between 0.1% by weight and 3% by weight, in relation to the composition ready for use.
 33. Composition according to claim 32, characterized in that the acyl radical of the N-acyl ethanolamine is a C1-C24-acyl radical.
 34. Composition according to claim 32, characterized in that the N-acyl ethanolamine is selected from the group which comprises N-acetyl ethanolamine, N-oleoyl ethanolamine, N-linolenoyl ethanolamine, N-cocoyl ethanolamine and N-palmitoyl ethanolamine.
 35. Composition according to claim 1, characterized in that the composition furthermore has at least one preservative, an antioxidant, a thickener and/or a gelling agent.
 36. Composition according to claim 35, characterized in that the composition has as thickener or respectively as gelling agent a natural colloid or a natural hydrocolloid and/or a synthetic colloid or a synthetic hydrocolloid.
 37. Composition according to claim 1, characterized in that the composition has respectively between 0.5% by weight and 7% by weight hydrogenated phosphatidylcholine, 0.5% by weight and 10% by weight cupuacu butter, 0.5% by weight and 15% by weight shea butter, 0.001% by weight and 3% by weight ceramids, 0.1% by weight and 5% by weight of the colloid or hydrocolloid, 2% by weight and 42% by weight of the oil or of the oil constituent, 0.01% by weight and 5% by weight of the active ingredient, 0% by weight and 10% by weight of other additives, and 5% by weight and 96% by weight water.
 38. Composition according to claim 1, characterized in that the composition is formulated as a composition which is able to be applied topically and has a viscosity at 20° C. between 2.000 mPas and 40.000 mPas, preferably between 12.000 mPas and 25.000 mPas.
 39. Composition according to claim 1, characterized in that the composition has a pH-value between 4.0 and 7.6.
 40. Composition according to claim 1, characterized in that the composition has the double membrane layer in a concentration between 10% and 95%, preferably between 30% and 95%, in relation to the weight of the carrier substance contained in the composition.
 41. Composition according to claim 1, characterized in that the composition contains a structure which comprises between 2 and 15 lamellar double membrane layers arranged one over the other in the manner of a sandwich.
 42. Composition according to claim 1, characterized in that each individual double membrane has a thickness between 4 nm and 20 nm, preferably between 4 nm and 8 nm.
 43. Composition according to claim 1, characterized in that the layer of the inner phase, arranged between adjacent double membrane layers, has a thickness between 2 nm and 10 nm. 